Clinical Trial Results:
An open, randomised, comparative, multicentre study of the immunogenicity and safety of M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® when administered concomitantly by intramuscular (IM) route or subcutaneous (SC) route at two separate injection sites in healthy subjects 12 to 18 months of age
Summary
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EudraCT number |
2004-002586-21 |
Trial protocol |
DE |
Global completion date |
05 Sep 2005
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Apr 2016
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First version publication date |
21 Jun 2015
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Other versions |
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Summary report(s) |
X04-MMRr-301 CSR Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.